globalmeet.webcasts.com
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Submitted URL: https://click.email.biopharminternational.com/?qs=a690cb7f3f22c7c625e814d43b9242a2fd7f47f32f2bfe371788d9784b9ab9ed2d31ad09235f222daba12686b3e1...
Effective URL: https://globalmeet.webcasts.com/starthere.jsp?ei=1607670&tp_key=a1cad498ad&sti=mjhemail
Submission: On May 25 via manual from IN — Scanned from DE
Effective URL: https://globalmeet.webcasts.com/starthere.jsp?ei=1607670&tp_key=a1cad498ad&sti=mjhemail
Submission: On May 25 via manual from IN — Scanned from DE
Form analysis 4 forms found in the DOM
POST /session-error.html?info=login
<form id="frmLogin" action="/session-error.html?info=login" method="post" autocomplete="">
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</form>POST /session-error.html?info=reg
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<option value="25e30c45681b7344f08fc4d2b59020a993d9f259">Isle of Man</option>
<option value="d99ff71dbb0ff1f765a990420a71182c9d7afbd4">Israel</option>
<option value="cc66848d46d1b430523e9fdf646e8b65d15d4c35">Italy</option>
<option value="afdf8c76c54f4dd68b322d39b3d0aceff8184edd">Jamaica</option>
<option value="7001dae5767bd1e69832363250ba9cf592a447d8">Japan</option>
<option value="e87cd0a46c46f9440a910729f6e7fcb7da203d71">Jersey</option>
<option value="1810e2c36651159d98a2e9b6a53f4e872ee0ec1b">Jordan</option>
<option value="b958fb615ece2e708d2e9313b0031570f7dfd103">Kazakhstan</option>
<option value="00c864f23b6f9a71f0a3762ac8dd3fe4d9be04f3">Kenya</option>
<option value="cb6033a7cd4c8e7c9328949a683d241a75073594">Kiribati</option>
<option value="5a642316507f824b5d15e0c441725ef5e322abbc">Korea, Democratic People's Republic of</option>
<option value="50929bcb2544a3cc14e12d3dbfed4e28ae49a321">Korea, Republic of</option>
<option value="b9ec08ddb323152d8b2d36f008b0844b63639867">Kuwait</option>
<option value="28ba30372ad4831af91b2942fc0b06fa7b3e531e">Kyrgyzstan</option>
<option value="e2ef6c074a850feeddd4c161312bda99280c29c7">Lao People's Democratic Republic</option>
<option value="841f2f79d06f4ff117965eda05ba3bf67b5f8440">Latvia</option>
<option value="f4324e4c9d6b07cb7914f59b55c78633c20543f7">Lebanon</option>
<option value="4f4360aea1a48eb8cfc220b203f3cd4c14ee60a5">Lesotho</option>
<option value="4fd814598278da5281af7bf46f77f5c74518bdeb">Liberia</option>
<option value="a83f510c125af64b5856144c6934582a99f4e198">Libyan Arab Jamahiriya</option>
<option value="9d05a19d6a05de8bdd18e1730139f65f841595d2">Liechtenstein</option>
<option value="4e62b4f60a74785d617940e09b84de609d2e9eda">Lithuania</option>
<option value="f8408b43443f0b20569f550568838c3bfd2aa48d">Luxembourg</option>
<option value="9a1897dc2d51a72c3326b11a22cb8526f845e729">Macao</option>
<option value="2441b1764f31b5b069cdd60ee55b5cfe0051f0d0">Madagascar</option>
<option value="a6f9460aac44b482faee6842fb52dc51e0d4eab2">Malawi</option>
<option value="838e04f3e4f01a9110af8f97f6c8752751740357">Malaysia</option>
<option value="a9150ae4571f66f48420bd26060aadf3124b1710">Maldives</option>
<option value="46a0db3ccce3cead4309d3a9dd058e5da2d51ed3">Mali</option>
<option value="61774b0b5ce834f1e50aa64510dcd02f426e6fc2">Malta</option>
<option value="628da8a5e64cea6d43829850c8fffb42c3ffbbbe">Marshall Islands</option>
<option value="36f35998e3f07aaf883b5e0e9879146f44374b38">Martinique</option>
<option value="65912d85da78f099e0d8c057eea0db83d3fb0869">Mauritania</option>
<option value="b25a1be0899460687fe562ab0b3b0b665ceabd49">Mauritius</option>
<option value="41bcdf6384f0d0338195ffa3cd00270f6ce3de21">Mayotte</option>
<option value="784721a059481bd2467e825609504ec80976442b">Mexico</option>
<option value="e283f1fcefd546d3cb29b1b9bbfe1e2206b4f020">Micronesia, Federated States of</option>
<option value="338764234a68a9ad0eaef7c4841f243dda6621ee">Moldova, Republic of</option>
<option value="fa493fbb9e3017c2d9bb04237ff888a89fbed279">Monaco</option>
<option value="889e2e43b974da9b2fb7041e48c0adbdf72b0d71">Mongolia</option>
<option value="b74e57b883b0f55485cef8b9d26701346cf9d175">Montenegro</option>
<option value="7a1ab17023beb199f015d68d3c61b55bb955f783">Montserrat</option>
<option value="bc33e1509119fb55ce3fafe51bf66bcd25f8721c">Morocco</option>
<option value="36b0482b78e9d41bff99471c8f4eb6397ea3b2e8">Mozambique</option>
<option value="2e3935ca00a76248b678e7fc6ebb210ce1cf61bd">Myanmar</option>
<option value="0ffcc1abbeee705819f39bb14456344e4ea4ffdf">Namibia</option>
<option value="82e39cb3d4a8585fb543aed626dcbd4c5003ba9f">Nauru</option>
<option value="ff6f7f31448fd418965835f74c8b330e5ea510a1">Nepal</option>
<option value="91618b348a6d317b0c4050b81bf3fe6be85a79e9">Netherlands</option>
<option value="4ef49bb2f5db6eacbc9dbc4057939aac184faf62">New Caledonia</option>
<option value="fb2f555dc94b36d98b1cff2eff8b800b642eeb46">New Zealand</option>
<option value="4178bc076806309bf7ec00e24b9b445648cd3287">Nicaragua</option>
<option value="cec320148ab719663f1cdd957d2dda98800e941e">Niger</option>
<option value="f6be3f2b5924b17693116563b75a55d5b37f0aee">Nigeria</option>
<option value="88f307c14ba31bd01dfd0af78234fd613b57e3e0">Niue</option>
<option value="0268859cbbf7f3e52caf3d200ae11c2a27fb83e8">Norfolk Island</option>
<option value="a4368a4d31c3f6592cd629cbe6220262942d532f">North Macedonia, Republic of</option>
<option value="faadfb5b73705980e25b10186e14741793ce8de0">Northern Mariana Islands</option>
<option value="c4453901db22493ecbea4d85b5ba7a168b7e6334">Norway</option>
<option value="2cd129c3038877ed7b0aa8b31d09101aed8b3ffe">Oman</option>
<option value="590b1caaa40730453c3ba888e01baf1ae7a45ea3">Pakistan</option>
<option value="3c7808541b20487f93f4568be718d067b1be6887">Palau</option>
<option value="3b132bde69318babd2b03eeca4c6568006e8a8a6">Palestinian Territory, Occupied</option>
<option value="cafa498c33a1790b29d5e44bb749e7ca100e50a8">Panama</option>
<option value="6e01cb2e7cd594e0693fc6e5fb300edc3dc90be3">Papua New Guinea</option>
<option value="5f3b42be8e95755e8ed8aff880c9201f739e8c04">Paraguay</option>
<option value="0774486a1c351a75a48daeb9263c8afdfcc23c85">Peru</option>
<option value="18b731a02644b9ccdb642cd4a6edf8989a04e92b">Philippines</option>
<option value="5e684848e348f47872c5c239e4bd2fee48569e31">Pitcairn</option>
<option value="a06ca1dcef277f1dc086c073c492d6801732be0d">Poland</option>
<option value="a24df48b9e96ab4b070d4659e53a3391847500a0">Portugal</option>
<option value="ccb56acb470dfab3e44b6bdc94a420d9ec7700e6">Puerto Rico</option>
<option value="ac329c70a3d072f9c5c014059138e3cebd047c09">Qatar</option>
<option value="e0fb6caf49aca9eb816135326051b055e179e2d3">Réunion</option>
<option value="9db5321997e380c3ae8f4d7bb25eb866da32792e">Romania</option>
<option value="e300822ae86d8945587e5860dd725404e40ede5f">Russian Federation</option>
<option value="397317f97d3d036ad5a997ec210b61c5ad7852bc">Rwanda</option>
<option value="b90cbc1d9c4fd67eca2f8cc9ffeb1d2b9a76190e">Saint Barthélemy</option>
<option value="405345075a8e7c1919566a9263bc5a9fd9fb3b24">Saint Helena</option>
<option value="c1e0eacfbef17881bc449ad9abe392a93208a0b9">Saint Kitts and Nevis</option>
<option value="4b5e15e0f7ee9626b53008dc0145e6dfb4783931">Saint Lucia</option>
<option value="29d44f1fec5944bb124b6e3ff916e6bd4a723c04">Saint Martin (French Part)</option>
<option value="b79495f43c5a211e08b6bac44fc3a27580ea31c1">Saint Pierre and Miquelon</option>
<option value="a25ff864672602072a5420b08d7a368cb38509f4">Saint Vincent and the Grenadines</option>
<option value="5c295c8d7f8e9266716451f6d6299319abe66ed4">Samoa</option>
<option value="d98a50e9b893185ab9ee373cfb5c3f40cfff6d44">San marino</option>
<option value="c209a582d55b53f32dc41da2ab9e70a78592c790">Sao Tome and Principe</option>
<option value="5398dbe92ce1f50489db381675e3399dec12fff0">Saudi Arabia</option>
<option value="03f276339ae8aca9672c705e40a7c91eed7434fa">Senegal</option>
<option value="acb71884ffd685d01d0a1912f4ba138b268e560b">Serbia</option>
<option value="1b486e228030306b6b8ff01f16643bb07f308609">Seychelles</option>
<option value="4a38da2147ba3cb9794ee87fb618ecf01591a5c8">Sierra Leone</option>
<option value="7bd69232166a12bf54c5bc8fb9763c094edd1f72">Singapore</option>
<option value="e6a19d757a09b7f358758bdab26c70f0ca24ab71">Sint Maarten (Dutch Part)</option>
<option value="592449e2309f6899fba71ab62742d6507c396a52">Slovakia</option>
<option value="bf186fbf9ff60f61405e1cb418949032d64f7b59">Slovenia</option>
<option value="406d0102bd39208c5260593d6c87e5b77fb5bd73">Solomon Islands</option>
<option value="5b74f2611a66dc0573f0c72934676272d3f3fee0">Somalia</option>
<option value="478c7685909ff2d92913d22c7d931600e3f65779">South Africa</option>
<option value="4cb93c14451d3642279f58fb539e8e055bf03a29">South Georgia and the South Sandwich Islands</option>
<option value="1718af1171e8dd4383ab56e3e86427e1446f1742">Spain</option>
<option value="24911e7b2bc59a011c82b06310ca2f1b36a7d570">Sri Lanka</option>
<option value="9adc8b19259adcfa4a9828ca65e43016cf18ed0a">Sudan</option>
<option value="b6ab12253f436bc7c4be8cc629183ae94fedf8ea">Suriname</option>
<option value="b206869ec864fbc45cc661deaceaa5d86a5c5815">Svalbard and Jan Mayen</option>
<option value="b1bccded135f839a9cacffa5b568281dbb9cfbb7">Swaziland</option>
<option value="704f74323478cece948cf270335f82f12a5e7cbe">Sweden</option>
<option value="a2a5853303cad01b6cd0eaa693dc10349163348e">Switzerland</option>
<option value="f69e2945b74f7bb040edfa9db764ef4e53083618">Syrian Arab Republic</option>
<option value="3a6fc49f454eaace75354bad5aca48abc34d29a6">Taiwan</option>
<option value="5d06fbee4387b18dea31801bd43f1d45f34b80f6">Tajikistan</option>
<option value="5a6e33eaafe3be1b9ec06801976b6d6f1dd5adc3">Tanzania, United Republic of</option>
<option value="daa363705b3350641afc67305b0d2824f429f013">Thailand</option>
<option value="242ddcdc13321b36ff7a6f4d07fb615b47606813">Timor-leste</option>
<option value="e6c48d8919ecef72a6a10eef95e648387a08fdbf">Togo</option>
<option value="4a71017e86777abe9d45cb9b13827d05aa3e8f8f">Tokelau</option>
<option value="0a3fe03f50117b233bc1fd504f76d0b85a6377df">Tonga</option>
<option value="e59546875d9185b05a6fff556bfbde9d3769e566">Trinidad and Tobago</option>
<option value="17e846f7d687907c4089cc0c05dfa5ff1075a6c8">Tunisia</option>
<option value="a4b184d68d579ba3eaec3d296e6ff816da089117">Turkey</option>
<option value="ff68b11d5e198a5de44edbdc10aa96b51ddebbdc">Turkmenistan</option>
<option value="3679c156ff612f9f3b1d86cbf678906e2452befb">Turks and Caicos Islands</option>
<option value="3cc2837024038110a331e9c83460aedc750ec1e1">Tuvalu</option>
<option value="8f96d6136f2ee4e7ceeca79f9073cd08dd3953e3">Uganda</option>
<option value="dda35ff1f2a24ebf0b7609e0232edcf907050e15">Ukraine</option>
<option value="82d4ef116265a2190527db4aadcf5c2bcd16d4af">United Arab Emirates</option>
<option value="f1c35f7b8bc18395c3a984bc33cb01a0281337bb">United Kingdom</option>
<option value="5f5c27cc9f2b0a9e4b52d066237d9ec952b9a4bd">United States Minor Outlying Islands</option>
<option value="151ec4f95df739dc9694d79237c75f798fc52b82">United States of America</option>
<option value="3670fefe325f29170cf344c58f387a9427ffbda8">Uruguay</option>
<option value="b4966fe0aed1d5ab2ec6f4e6c5fbe5bc4170e595">Uzbekistan</option>
<option value="d3d747c0b53a7892ff2ae164f19d9c7358a5a0c4">Vanuatu</option>
<option value="e91bb8669d01ea6378150fae5e3062c8cd95d312">Venezuela, Bolivarian Republic of</option>
<option value="b51d7e7c04f88149969fa57af5d5581ce5b7bb10">Viet Nam</option>
<option value="582da7e8fa37af8b9d0da80360bb51190ac5336f">Virgin Islands, British</option>
<option value="bc6f1ca687dc5387405b41bfae1bebd74c2fec00">Virgin Islands, U.S.</option>
<option value="b6e92d8c2f8ddf7bfd1fd5c94136c9d1dbd0ea49">Wallis and Futuna</option>
<option value="591904a1c313d59da62a4706c65f6aeafbc10f7f">Western Sahara</option>
<option value="3e0d86e27f78570ef73c03685c7ebc5e9f16416e">Yemen</option>
<option value="fccf28c397ee4f5904b29d175b8a587ed80a7adf">Zambia</option>
<option value="ea0695b2e4ccb2290ab27dc8bbda2bf19f68fcf6">Zimbabwe</option>
</select>
</span>
<span id="opt_cf3e1d50d0fede72e3d7ff75f5efd49b9630e396">
<label for="cf3e1d50d0fede72e3d7ff75f5efd49b9630e396">Business Phone:</label>
<input type="tel" id="cf3e1d50d0fede72e3d7ff75f5efd49b9630e396" name="cf3e1d50d0fede72e3d7ff75f5efd49b9630e396" title="Business Phone" value="" size="35" maxlength="100">
</span>
<span id="opt_3364722166f2f2a91bc8128f3d90a324b6ee84b5">
<label for="3364722166f2f2a91bc8128f3d90a324b6ee84b5">Which best describes your job function?:</label>
<select id="3364722166f2f2a91bc8128f3d90a324b6ee84b5" name="3364722166f2f2a91bc8128f3d90a324b6ee84b5" title="Which best describes your job function?">
<option value="">--</option>
<option value="97de3555b792cc672c3a5e690b018c237a91c9d8">Clinical Research</option>
<option value="99ddf21e227c24cf981bab65cd95054df59f0fdf">Commercial Operations</option>
<option value="3299e523df08fbee43a5886ebf53599dbeb9d737">Commercialization</option>
<option value="ba565bb9d600625e92972e4c6492a8ae2dbd8210">Compliance</option>
<option value="4f7d4404d9e2fa890dd13c8689e7e4da0553a231">Consultant</option>
<option value="a1d947fec0e36b7bcb7b7914dd8dfc7bebb69c92">Contract Services</option>
<option value="f5e6abddff81a013a0a6a070d593ef1069080aab">Corporate Management</option>
<option value="2123e7f9bca88b5f32bc000b7f301b4780e7a136">Drug Safety</option>
<option value="ef85ad753eef554c5f4d1383ef387baeebf3bc3b">Engineering</option>
<option value="ee330077f8cc3c69a4083f027e391b483f6f88f4">Environmental</option>
<option value="05095479f1183ec8cdb015997ed2f0e7b491b747">Finance</option>
<option value="93f7dda7ed7655a7babf1a5595add9740e2d91fe">HR</option>
<option value="0710cdc41314d31c4466f9d5d07d0ba8ea18dcce">IT</option>
<option value="6f1ee4f436dc100be286e06e2d3e178fcad767af">Lab Management</option>
<option value="90707b5929c2a23c1cc0b69c49a7caa1d3360f28">Legal</option>
<option value="9576c0bb010bd5ecd0276451bfbc1a85bf296b6d">Managed Care</option>
<option value="e28800ebd3ec044273876b1a04ee0b29561e3d2c">Manufacturing/Processing</option>
<option value="c38636740660caf50f6f90a4b9b129873d31eea4">Market Research</option>
<option value="6bb4ffa08b0312caf2eb83294fbbb0e66622b873">Marketing</option>
<option value="8d9344068cf4ef907ff665380712c241806ad721">Media Planning</option>
<option value="dad93ca43c7f6fe517c5785a5510b143f3ce640e">Medical Affairs</option>
<option value="5abf8f8594e5f8ab8e0d9e71d74924b39fdaa8a0">Medicare/Medicaid</option>
<option value="a5832b5e97fb259da46242d277af3047020e501d">Meeting Planner</option>
<option value="40c169d9b2d603df48f4d968e99afbe1672ea1b5">Other</option>
<option value="ee5e22bf4da33432f4e4ae73d6f1287b1c34b943">Packaging</option>
<option value="43da8421a957eedd31d0091f24f3069d8178fa95">Patient Programs/Services</option>
<option value="f80d0e739bd1d96682630489edfe09d4b40415c5">Pharmacy</option>
<option value="e02907afb46211932dc2a8982ab15851771dff1b">Procurement</option>
<option value="f525ac92102909c806a824c1981c2bed6f7c2e1e">Project Management</option>
<option value="d3a78c1a7964df1aff1391644e91dc7effa0bc01">QA/QC</option>
<option value="a242c36bd6494ef9e292e25bad5bd6591a97aa33">R&D</option>
<option value="c8fd50146ee2a84dc862d76a5b8cb7406f0ba51e">Regulatory Affairs</option>
<option value="a00e56947733acaad83d2396c119927152f30b2d">Reimbursement</option>
<option value="7d5d97fee93a2bd5621d77272524084218b5096c">Sales Management</option>
<option value="0dacc0e01ad5c5d7b03032cdb330b2781fa02dff">Scientific</option>
<option value="1c8a5024afea54e02aac14b2694832ae8114ea1d">Supply Chain</option>
<option value="af76b7d40d1bcd8e6a1ec3fd844a83dd2e20b5d6">Technology Transfer</option>
<option value="186e29bbcd19b113e48ef176f2b3769ca6c6ba49">Trade/Sales</option>
<option value="d0b9f33188560ce42732376a5f1288bac73e8a06">Validation</option>
<option value="a3519209ab8118de066e12fa16b98c136243dbdd">X-Outcomes</option>
</select>
</span>
<span id="opt_bad147232de0d84735316745799c12572f8506ca">
<label for="bad147232de0d84735316745799c12572f8506ca">Which best describes your business/industry?:</label>
<select id="bad147232de0d84735316745799c12572f8506ca" name="bad147232de0d84735316745799c12572f8506ca" title="Which best describes your business/industry?">
<option value="">--</option>
<option value="ad8440f916d26f76e8bd859f4a5b84512631043b">Academic</option>
<option value="fb0c7b8d327d2cae42d58d1c831d18cba0c48ab3">Audit & Financial Advisory</option>
<option value="91005c156b55deba37753c6beedf9bb741c60c02">Biopharma</option>
<option value="925032aaa556baec407dd7ec3ba3a99f8243a081">Bio Pharmaceutical</option>
<option value="93f24c13d87b42e79f17745f87aed33490c125f1">Biotech</option>
<option value="1c16c69e6c2c46329f7b1bf075027e5b6330551c">Consultant</option>
<option value="10fd49be3bdc05f5e3b6b3ee07a41b923eaf9a90">Contract Manufacturing Organization (CMO)</option>
<option value="25d8addb1ea5bd22ca709b02bb2b46f2725831d8">Contract Research Organization (CRO)</option>
<option value="feda02f427b1f85f45648cda4f6cd050c68554b0">Convention/Visitors Bureau</option>
<option value="257fe64aaa3653d302d3a17e0816bd7f9cae6ea6">Data Management/Technology Provider</option>
<option value="f28fe103e4dd9842b182437ff3c0abce97cdc712">Diagnostics</option>
<option value="5a38837b8486fa95b29d80fb78d0c5e3818db307">DMC (Destination Management Company)</option>
<option value="8845f4007edfb6ac519e910443098a2cc2903f11">Food</option>
<option value="b3ca5141167f1f1859e1196ca3f9dcd09c657715">Government</option>
<option value="daf93b569ebd22eaeb3d190f407bd55f13ab473b">Health Plan/Payer</option>
<option value="2a6518617e2add895b188a0a613f5a2458264c70">Hospital/Medical Centers</option>
<option value="c373d088fcbcf3a351023c066a4559885a7cc230">Hotel</option>
<option value="e798f0d53f706e0cd28f04ef56a7f6046d3f19b7">Laboratory</option>
<option value="a1a4b56b02744eb616011456d849e61e577b26fd">Legal/Law Firm</option>
<option value="4292aa56e6f5ed697d454feebd398e5a611c1a9e">Marketing/Creative Agency</option>
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<strong fr-original-style="font-weight: 700;" style="font-weight: 700;"><u>Event Overview</u></strong>
<div data-empty="true"><br></div>Protein-based biotherapeutics are produced by numerous prokaryotic and eukaryotic cellular expression systems. During the manufacture of these products, host cell proteins (HCPs) are a significant class of
process-related impurities that are coproduced with the desired product. <em>USP</em> General Chapter <1132> <em>Residual Host Cell Protein Measurement in Biopharmaceuticals</em> includes detailed information on the design, validation, and
implementation of reagents and immunoassays used to measure these residual HCPs. A new proposed chapter builds on <1132> and provides an overview of the capability of Mass Spectrometry (MS) methods for HCP identification and quantitation.
This seminar will describe best practices for instrument selection, sample preparation, liquid chromatography (LC) separation, MS data acquisition, MS data analysis and reporting, with particular attention to the orthogonality of MS and traditional
methods.<br><br><strong><u>Key Learning Objectives</u></strong><br>
<ul>
<li>To understand the importance of Host Cell Protein Analysis in biopharmaceutical development.</li>
<li>To become familiar with current technologies and best practices for analysis of HCP by LC-MS</li>
<li>To understand the applications for and orthogonal relationship of LC-MS and traditional methods for HCP analysis.</li>
</ul><strong><u>Who Should Attend</u></strong><br>
<ul>
<li>Scientists, managers and regulatory experts responsible for manufacture and testing of biologics destined for clinical trials. </li>
</ul>
<hr style="clear: both;user-select: none;break-after: page;" fr-original-style="clear: both; user-select: none; break-after: page;">
<div data-empty="true"><br></div>
<div style="text-align: center;"><strong fr-original-style="font-weight: 700;" style="font-weight: 700;"><u>Featured Speakers</u></strong></div><br>
<div contenteditable="false" fr-original-class="headshots" fr-original-style="display:flex;justify-content:center;flex-wrap:wrap;flex-direction:column; align-items:center;"
style="display: flex;justify-content: center;flex-flow: column wrap;align-items: center;user-select: none;">
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src="https://cache.webcasts.com/content/pgic001/1607670/content/a1cad498ad33a88e52ab75cc2af6700e00f2d01f/common/NiomiPeckham.png" alt="Niomi Peckham" style="border-radius: 100.0px;cursor: default;position: relative;max-width: 100.0%;"
width="100px" height="100px" fr-original-style="border-radius: 100px; cursor: default;" fr-original-class="headshotImg0 fr-draggable"></div>
<div class="rightContainer" style="display: flex;flex-direction: column;justify-content: center;align-items: flex-start;width: 200.0px;text-align: left;">
<div style="margin: 2.0px 0;width: 100.0%;">
<div class="name" style="font-size: 18.0px;word-wrap: break-word;">Niomi Peckham</div>
</div>
<div style="width: 100.0%;">
<div class="title" style="font-size: 12.0px;word-wrap: break-word;">Director of Pipeline Development, Global Biologics</div>
</div>
<div style="width: 100.0%;">
<div class="company" style="font-size: 12.0px;word-wrap: break-word;">United States Pharmacopeia</div>
</div>
</div>
</div>
</div><br><strong fr-original-style="font-weight: 700;" style="font-weight: 700;">Niomi </strong><strong fr-original-style="font-weight: 700;" style="font-weight: 700;">Peckham</strong> is the Director of Pipeline Development in USP Global
Biologics. She works with scientific experts and stakeholders to develop standards for assays used to support biopharmaceutical quality assessment and development. Niomi has worked for several biotechnology and diagnostic companies but has spent
most of her career at Pfizer and Alexion Pharmaceuticals, focusing on development of protein-based biopharmaceuticals. She has been responsible for development, validation, transfer, and lifecycle management of analytical methods for
biopharmaceuticals from pre-clinical through commercialization. Her particular focus has been on analysis of host cell proteins.<br><br>Niomi holds a Bachelor of Science in Biotechnology from the University of Connecticut, a Master of Science in
Molecular and Cellular Biology from the State University of New York at Stony Brook, and a Graduate Certificate in Drug Development from Temple University.<br><br><strong fr-original-style="font-weight: 700;" style="font-weight: 700;">Speaker’s
Email: </strong><span
style="color: rgb(239,239,239);"><a fr-original-style="user-select: auto;" href="mailto:niomi.peckham@USP.org" rel="noopener noreferrer" style="user-select: auto;color: inherit;" target="_blank">niomi.peckham@USP.org</a></span><br><strong
fr-original-style="font-weight: 700;" style="font-weight: 700;">Speaker’s LinkedIn: </strong><span
style="color: rgb(239,239,239);"><a fr-original-style="user-select: auto;" href="https://www.linkedin.com/in/niomi-peckham/" rel="noopener noreferrer" style="user-select: auto;color: inherit;" target="_blank">https://www.linkedin.com/in/niomi-peckham/</a></span><br>
<div data-empty="true"><br></div>
<div contenteditable="false" fr-original-class="headshots" fr-original-style="display:flex;justify-content:center;flex-wrap:wrap;flex-direction:column; align-items:center;"
style="display: flex;justify-content: center;flex-flow: column wrap;align-items: center;user-select: none;">
<div class="headshot0 headshot" style="text-align: center;margin: 10.0px;display: flex;">
<div class="leftContainer" style="display: flex;flex-direction: column;align-self: center;margin-right: 10.0px;"><img src="https://cache.webcasts.com/content/pgic001/1607670/content/a1cad498ad33a88e52ab75cc2af6700e00f2d01f/common/NedMozier.png"
alt="Ned Mozier" style="border-radius: 100.0px;cursor: default;position: relative;max-width: 100.0%;" width="100px" height="100px" fr-original-style="border-radius: 100px; cursor: default;" fr-original-class="headshotImg0 fr-draggable">
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<div style="margin: 2.0px 0;width: 100.0%;">
<div class="name" style="font-size: 18.0px;word-wrap: break-word;">Ned Mozier</div>
</div>
<div style="width: 100.0%;">
<div class="title" style="font-size: 12.0px;word-wrap: break-word;">Vice President, Biotherapeutics Pharmaceutical Sciences</div>
</div>
<div style="width: 100.0%;">
<div class="company" style="font-size: 12.0px;word-wrap: break-word;">Pfizer</div>
</div>
</div>
</div>
</div><br><strong fr-original-style="font-weight: 700;" style="font-weight: 700;">Ned Mozier</strong> group is responsible for CMC teams for 40-50 projects in Pfizer clinical trials, including the coordination of authoring and reviewing of
regulatory submissions to assure on-time delivery. This group is responsible for BTxPS committees that manage the early projects entering Pfizer’s pipeline and resolve key project conflicts and authorize critical strategies. Achievement of key
milestones (within budget and on time) as well as risks of delay or major budget change are communicated proactively. Milestone goals and achievements are tracked for all standard, accelerated, and Lightspeed projects. His group manages the
internal manufacturing capacity as well as the outsourcing function, in which smooth transitions of projects from early to later stages are a priority. Project leadership and management from this group contributes to Pfizer’s mission of delivering
25 breakthrough products to patients by 2025. The transfer of out-licensed projects is also managed in collaboration with the Transformative Technology group.<br><br>Ned obtained his Ph.D. in biochemistry from the University of Louisville in 1988,
which prepared him for a career in the biotechnology sector. After postdoctoral research at The Upjohn Company and two years at Baxter Healthcare’s blood substitutes division, Ned has worked for Pfizer and legacy companies. He has led
co-development projects and contributed to many approved products, including establishment of the structure function relationships for biosimilars.<br><br><strong fr-original-style="font-weight: 700;" style="font-weight: 700;">Speaker’s
Email: </strong><span
style="color: rgb(239,239,239);"><a fr-original-style="user-select: auto;" href="mailto:ned.m.mozier@pfizer.com" rel="noopener noreferrer" style="user-select: auto;color: inherit;" target="_blank">ned.m.mozier@pfizer.com</a></span><br><strong
fr-original-style="font-weight: 700;" style="font-weight: 700;">Speaker’s LinkedIn:<span style="color: rgb(239,239,239);"> </span></strong><span
style="color: rgb(239,239,239);"><a href="https://www.linkedin.com/in/ned-mozier-49970a11" style="user-select: auto;color: inherit;" fr-original-style="user-select: auto;"></a><a fr-original-style="user-select: auto;" href="https://www.linkedin.com/in/ned-mozier-49970a11" rel="noopener noreferrer" style="user-select: auto;color: inherit;" target="_blank">https://www.linkedin.com/in/ned-mozier-49970a11</a></span><br><br>
<hr>For any technical questions please contact <strong fr-original-style="font-weight: 700;" style="font-weight: 700;">Jorge de la Bandera</strong>:<span
style="color: rgb(239,239,239);"> <a fr-original-style="user-select: auto;" href="mailto:JdelaBandera@mjhlifesciences.com" rel="noopener noreferrer" style="user-select: auto;color: inherit;" target="_blank">JdelaBandera@mjhlifesciences.com </a></span>
<hr><span style="font-family: verdana , geneva;"></span><br>Protein-based biotherapeutics are produced by numerous prokaryotic and eukaryotic cellular expression systems. During the manufacture of these products, host cell proteins (HCPs) are a
significant class of process-related impurities that are coproduced with the desired product. <em>USP</em> General Chapter <1132> <em>Residual Host Cell Protein Measurement in Biopharmaceuticals</em> includes detailed information on the
design, validation, and implementation of reagents and immunoassays used to measure these residual HCPs. A new proposed chapter builds on <1132> and provides an overview of the capability of Mass Spectrometry (MS) methods for HCP
identification and quantitation. This seminar will describe best practices for instrument selection, sample preparation, liquid chromatography (LC) separation, MS data acquisition, MS data analysis and reporting, with particular attention to the
orthogonality of MS and traditional methods.<br><strong><u> </u></strong><br><strong><u>Key Learning Objectives:</u></strong><strong><u> </u></strong><br>
<ul>
<li>To understand the importance of Host Cell Protein Analysis in biopharmaceutical development.</li>
<li>To become familiar with current technologies and best practices for analysis of HCP by LC-MS</li>
<li>To understand the applications for and orthogonal relationship of LC-MS and traditional methods for HCP analysis.</li>
</ul><strong><u>Who Should Attend: </u></strong><br>
<ul>
<li>Scientists, managers and regulatory experts responsible for manufacture and testing of biologics destined for clinical trials. </li>
</ul>
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free e-newsletters. By registering for this event, you agree to MJH Life Sciences ® Terms and Conditions, Privacy Policy, and understand your data will be used by MJH and its affiliates for amongst other things, alerting you to other services or products that you maybe interested in, and may be shared with or sold to third parties for their use, including possible contact with you through email or other communications, consistent with their respective privacy policy. If you do not agree to have your data used in this way, please contact info@mjhassoc.com. *Denotes required. BEST PRACTICES FOR RESIDUAL HOST CELL PROTEIN MEASUREMENT IN BIOPHARMACEUTICALS BY MASS SPECTROMETRY: USP CHAPTER 1132.1 WED, MAY 31, 2023 11:00 AM EDT (3:00 PM GMT) ADD TO CALENDAR Event Overview Protein-based biotherapeutics are produced by numerous prokaryotic and eukaryotic cellular expression systems. During the manufacture of these products, host cell proteins (HCPs) are a significant class of process-related impurities that are coproduced with the desired product. USP General Chapter <1132> Residual Host Cell Protein Measurement in Biopharmaceuticals includes detailed information on the design, validation, and implementation of reagents and immunoassays used to measure these residual HCPs. A new proposed chapter builds on <1132> and provides an overview of the capability of Mass Spectrometry (MS) methods for HCP identification and quantitation. This seminar will describe best practices for instrument selection, sample preparation, liquid chromatography (LC) separation, MS data acquisition, MS data analysis and reporting, with particular attention to the orthogonality of MS and traditional methods. Key Learning Objectives * To understand the importance of Host Cell Protein Analysis in biopharmaceutical development. * To become familiar with current technologies and best practices for analysis of HCP by LC-MS * To understand the applications for and orthogonal relationship of LC-MS and traditional methods for HCP analysis. Who Should Attend * Scientists, managers and regulatory experts responsible for manufacture and testing of biologics destined for clinical trials. -------------------------------------------------------------------------------- Featured Speakers Niomi Peckham Director of Pipeline Development, Global Biologics United States Pharmacopeia Niomi Peckham is the Director of Pipeline Development in USP Global Biologics. She works with scientific experts and stakeholders to develop standards for assays used to support biopharmaceutical quality assessment and development. Niomi has worked for several biotechnology and diagnostic companies but has spent most of her career at Pfizer and Alexion Pharmaceuticals, focusing on development of protein-based biopharmaceuticals. She has been responsible for development, validation, transfer, and lifecycle management of analytical methods for biopharmaceuticals from pre-clinical through commercialization. Her particular focus has been on analysis of host cell proteins. Niomi holds a Bachelor of Science in Biotechnology from the University of Connecticut, a Master of Science in Molecular and Cellular Biology from the State University of New York at Stony Brook, and a Graduate Certificate in Drug Development from Temple University. Speaker’s Email: niomi.peckham@USP.org Speaker’s LinkedIn: https://www.linkedin.com/in/niomi-peckham/ Ned Mozier Vice President, Biotherapeutics Pharmaceutical Sciences Pfizer Ned Mozier group is responsible for CMC teams for 40-50 projects in Pfizer clinical trials, including the coordination of authoring and reviewing of regulatory submissions to assure on-time delivery. This group is responsible for BTxPS committees that manage the early projects entering Pfizer’s pipeline and resolve key project conflicts and authorize critical strategies. Achievement of key milestones (within budget and on time) as well as risks of delay or major budget change are communicated proactively. Milestone goals and achievements are tracked for all standard, accelerated, and Lightspeed projects. His group manages the internal manufacturing capacity as well as the outsourcing function, in which smooth transitions of projects from early to later stages are a priority. Project leadership and management from this group contributes to Pfizer’s mission of delivering 25 breakthrough products to patients by 2025. The transfer of out-licensed projects is also managed in collaboration with the Transformative Technology group. Ned obtained his Ph.D. in biochemistry from the University of Louisville in 1988, which prepared him for a career in the biotechnology sector. After postdoctoral research at The Upjohn Company and two years at Baxter Healthcare’s blood substitutes division, Ned has worked for Pfizer and legacy companies. He has led co-development projects and contributed to many approved products, including establishment of the structure function relationships for biosimilars. Speaker’s Email: ned.m.mozier@pfizer.com Speaker’s LinkedIn: https://www.linkedin.com/in/ned-mozier-49970a11 -------------------------------------------------------------------------------- For any technical questions please contact Jorge de la Bandera: JdelaBandera@mjhlifesciences.com -------------------------------------------------------------------------------- Protein-based biotherapeutics are produced by numerous prokaryotic and eukaryotic cellular expression systems. During the manufacture of these products, host cell proteins (HCPs) are a significant class of process-related impurities that are coproduced with the desired product. USP General Chapter <1132> Residual Host Cell Protein Measurement in Biopharmaceuticals includes detailed information on the design, validation, and implementation of reagents and immunoassays used to measure these residual HCPs. A new proposed chapter builds on <1132> and provides an overview of the capability of Mass Spectrometry (MS) methods for HCP identification and quantitation. This seminar will describe best practices for instrument selection, sample preparation, liquid chromatography (LC) separation, MS data acquisition, MS data analysis and reporting, with particular attention to the orthogonality of MS and traditional methods. Key Learning Objectives: * To understand the importance of Host Cell Protein Analysis in biopharmaceutical development. * To become familiar with current technologies and best practices for analysis of HCP by LC-MS * To understand the applications for and orthogonal relationship of LC-MS and traditional methods for HCP analysis. Who Should Attend: * Scientists, managers and regulatory experts responsible for manufacture and testing of biologics destined for clinical trials. FAQs and System Test * Outlook ❯ * Google ❯